Risky Therapeutic And Diagnostic Procedures And Environmental Influences; Electrical And Electromagnetic Safety; Handling And Implantation; Basic Advice And Precautionary Measures For The Implantation - BIOTRONIK Sentus ProMRI OTW BP L Manuel Technique

Risky Therapeutic and Diagnostic Procedures and
Environmental Influences
Improper procedures
The procedures listed in the following table must be avoided for patients with an
implanted lead or a device system (pacemaker or ICD).
Procedure Type of danger
Diathermy • Tissue damage due to excessive heating of the
lead
• Induction of ventricular fibrillation
Magnetic resonance imaging • Tissue damage due to excessive heating of the
(Please read the explanation lead
at the end of this section.) • Change of position of the lead (lead dislodgement)
or the active device
• Pulse inhibition, asynchronous and/or triggered
pulse delivery by the active device
Hyperbaric oxygen therapy • Penetration of bodily fluids into the lead or device
Transcutaneous electrical • Induction of ventricular fibrillation
nerve stimulation (TENS),
stimulation current
Note: Tissue damage due to excessive heating usually causes change or loss of the
sensing and pacing function of the implanted lead.
Magnetic resonance imaging
Magnetic resonance imaging is contraindicated due to the associated high frequency
fields and magnetic flux density.
• Patients with an implanted lead of this type may be examined using magnetic
resonance imaging only when specific measures have been taken to ensure the
safety of the patient and device.
• Please contact the responsible authorities or BIOTRONIK beforehand to determine
whether these products are actually certified "MR conditional" in your country or
region.
• You can find detailed information about the requirements,
conditions and measures for safely conducting an MRI scan in
our manual "ProMRI ® , MR conditional device systems."
You can download this manual as a PDF file from
www.biotronik.com/manuals/manualselection or 
https://manuals.biotronik.com or order a printed copy from
BIOTRONIK.
Risky procedures
The table below provides an overview of procedures that present a risk to patients with
an implanted lead or a device system. Take appropriate precautionary measures and
observe the specific instructions listed in the table.
Procedure Type of danger Recommendations for risk miti-
gation
Therapeutic ultra- Tissue damage due to Do not direct the energy focus
sound excessive heating of the onto the lead or the device.
lead Afterwards: perfom a full follow-
up.
External defibrilla- Tissue damage due to Afterwards: perfom a full follow-
tion excessive heating of the up.
lead
Electrophysiological Tissue damage due to Switch off the active device
ablation excessive heating of the beforehand.
lead Keep as much distance as
Induction of ventricular possible between the ablator and
fibrillation the lead.
Damage to the lead Following ablation and prior to
restarting the active device:
perfom a full follow-up.
HF surgery (electro- Tissue damage due to Do not direct the energy focus
cautery) excessive heating of the onto the lead or the device.
lead Afterwards: perfom a full follow-
Induction of ventricular up.
fibrillation
Lithotripsy Mechanical effect on or Keep energy focus from the lead.
damage to the lead Afterwards: perfom a full follow-
up.
Note: Tissue damage due to excessive heating usually causes change or loss of the
sensing and pacing function of the implanted lead.
Problematic environmental influences
• Increased ambient pressure:
The leads are manufactured under standard atmospheric pressure and are not
designed to withstand increased ambient pressure.
Stress resulting from excess pressure may damage the leads.
W CAUTION
Damage and failure of the device system
Patients with device systems must avoid situations or environments in which they
would be exposed to high ambient pressures (such as diving or pressure chambers).
• Electromagnetic interference:
Electromagnetic fields may negatively affect patients with device systems as the
intensity and duration of exposure increase. This can have the following conse-
quences:
— Temporary or permanent effect on or damage to the device system
— Induction of tachycardias, up to and including ventricular fibrillation (in rare
cases)
— Thermal tissue damage (in severe cases)
The patient should be properly informed and instructed on behaviors to avoid situa-
tions with especially risky electromagnetic effects.
Perform a follow-up for clarification if electromagnetic interference is suspected to
have impaired the function of the device system.
In most cases, the problem can be solved by reprogramming the device.

Electrical and Electromagnetic Safety

Electrical safety
Implanted leads are a direct electrical connection to the myocardium.
Therefore, it is important for the safety of the patient that no electrical energy - other
than the pulses from the active device - is conducted to the lead, neither by direct
contact nor indirectly due to electromagnetic conduction.
W WARNING
Risk of death due to induction of ventricular fibrillation
Ensure that the contact surfaces of the lead connectors of implanted leads never
touch any electrically conducting or wet surfaces, including human hands or skin.
Electromagnetic induction
A lead can receive electromagnetic energy as an antenna would and cause electrical
voltages at the lead tip and connector.
This can induce ventricular fibrillation in some cases, as well as damage or otherwise
affect the active device and, if the energy dose is high enough, even damage the
myocardium.
Note: For information about therapy or diagnostic procedures that pose a potential
risk, refer to the appropriate section of this manual (see Risky Therapeutic and
Diagnostic Procedures and Environmental Influences, p. 2).
Additional information
For further information about this topic and possibilities of risk mitigation, refer to the
manuals for BIOTRONIK active devices.
Preventing leakage currents
Leakage currents to the active device, the lead or directly to the myocardium must be
prevented, as they can trigger lethal arrhythmias.
Line-powered devices operated in the patient's vicinity must always be grounded
according to regulations. Otherwise, there is a danger of leakage currents caused by
such devices being conducted to the myocardium via the lead.
Only connect the lead to battery-powered measurement and pacing devices or to
devices that are classified as type CF (Cardiac Floating) applied parts complying with
EN 60601, and follow the instructions in the respective technical manuals.

3 Handling and Implantation

Basic Advice and Precautionary Measures for the
Implantation
• Always implant the lead using X-ray monitoring.
• Monitor the ECG carefully during implantation and keep external defibrillation
equipment and a pacing system analyzer on standby.
• Handle the lead with care. Any strong application of force, such as bending,
stretching and kinking, can permanently damage the lead.
• Do not perforate or damage the lead's insulation or coils when working with the
guide wire, the stylet, tweezers, or other surgical instruments.
• To prevent mechanical overstressing from causing failure of the pacing/sensing
function, make sure that the lead does not become pinched between the clavicle
and the first rib after implantation.
2
• Under no circumstances is the inner lumen of the lead to be rinsed with irrigation
fluid. The excess pressure inside the lead that results from this can damage the
silicone insulation.
• Ensure that the lead fixation sleeve is close to the connector, so that insertion and
positioning of the lead is not hindered.
• Always use the supplied lead fixation sleeve when implanting the lead. This will
reduce the risk of lead dislodgment and protect the lead body from possible
damage from a ligature.
Information on the procedure with guide wire (over-the-wire)
• Use only a guide wire with a maximum diameter of 0.36 mm (0.014 inches). Using
a guide wire with a larger diameter can cause lead damage.
• Make sure that the guide wire is not kinked.
• When inserting the proximal end of the guide wire into the lead tip:
— Take particular care to prevent damaging the lead insulation or the seal inside
the lead.
— You can reduce the force that needs to be applied and reduce the risk of
damaging the lead by keeping the distal pre-formed shape of the lead straight
until the guide wire is in this area.
— Despite the distal seal, a small amount of blood can enter the interior of the
lead together with the guide wire. In this case, the inner lumen must not be
rinsed, as the resulting excess pressure can damage the lead insulation.
Information on the procedure with stylet
• The stylet has a pre-shaped part near the handle, which can be used to lock the
stylet within the lead and maintain a certain prestress.
When inserting the stylet into the lead, be careful when exceeding the resistance
with this locking mechanism.
• Coagulated blood may impair the maneuverability of the stylet inside the lead.
— Ensure that no blood reaches the interior of the lead on, or with, the stylet.
Therefore, do not use a stylet that is wetted with blood.
— As far as possible, prevent blood from entering the lead from other pathways.
— In this case, the inner lumen must not be rinsed, as the resulting excess
pressure can damage the lead insulation.
— If needed, use a spare stylet or replace the lead with a new one.
• The use of unsuitable stylets or improper handling of the stylet can result in
damage to the lead.
This could result in malfunction or failure of the lead.
Moreover, the stylet could protrude from the lead tip and injure the patient.
— Use only a suitable stylet for the respective lead (based on length and
diameter). Refer to the Technical Data section for further information.
— Never use extremely curved or bent stylets.
Note: Spare stylets can be ordered individually as accessories.

Information on the Steroid Collar

Intended medical use
The lead tip has a steroid collar in the form of a silicone rubber ring that contains
dexamethasone acetate.
The intended effect is the reduction of the inflammatory processes after implantation
and the inflammation-related post-operative threshold increase (lead maturation
behavior).
W CAUTION
Premature elution of the steroid
Do not wipe the lead or immerse the lead in liquids any more than absolutely neces-
sary.
Long-term performance of the steroid eluant
The greater the elapsed time since the implantation, the more the original amount of
steroid is eluted.
Over time, the maturation behavior of the lead begins to resemble that of the same type
of lead without steroid-eluting properties. This aspect must be considered if a lead is to
be repositioned.

Opening the Package

Packaging composition
The lead and its accessories are sealed in two blisters, one within the other, and steril-
ized with ethylene oxide. As a result, the inner blister is also sterile on the outside.
You can remove the inner blister by using a standard aseptic technique and place it in
the sterile field.